Events

Rappel de NxStage Express Fluid Warmer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Regional Health Care Group Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00798-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00798-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
  • Action
    NxStage, through Regional Health Care Group have taken the decision to replace the Instructions for Use with an updated IFU.

Device

NxStage Express Fluid Warmer
  • Modèle / numéro de série
    NxStage Express Fluid Warmer Models: FW-300, FW-300-WW, FW-300-A, FW-301 and FW-301-AARTG Number: 289644(Regional Health Care Group - Conduction blood/fluid warmer)
  • Manufacturer
    Regional Health Care Group Pty Ltd

Manufacturer

Regional Health Care Group Pty Ltd